324 Participants Needed

PIPE-791 for Idiopathic Pulmonary Fibrosis

NN
MF
Overseen ByMarietta Franco
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Contineum Therapeutics
Must be taking: Antifibrotics
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called PIPE-791 for individuals with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that makes breathing difficult. Researchers aim to determine the safety and effectiveness of this treatment compared to a placebo (a look-alike with no active drug) and to understand its interaction with patients' bodies. Participants will be divided into groups to receive either one of two doses of PIPE-791 or a placebo. Candidates may qualify if diagnosed with IPF within the last 7 years and have not experienced any flare-ups in the past 6 weeks. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in IPF treatment.

Is there any evidence suggesting that PIPE-791 is likely to be safe for humans?

Research shows that PIPE-791 is generally well-tolerated. Earlier studies demonstrated a safety profile consistent with past research. For instance, PIPE-791 was tested for conditions like multiple sclerosis, which affects the brain and spinal cord, and was found to be safe. Both healthy volunteers and patients with this condition did not experience major safety issues when taking PIPE-791.

Although detailed safety data for idiopathic pulmonary fibrosis (IPF) is not yet available, the safety record from other studies is reassuring. However, as this is a Phase 2 trial, researchers are still gathering more detailed safety information for IPF. This phase typically assesses how well people can handle the treatment and any potential side effects.12345

Why do researchers think this study treatment might be promising for IPF?

PIPE-791 is unique because it offers a new approach to treating idiopathic pulmonary fibrosis (IPF). While most current treatments, like pirfenidone and nintedanib, primarily aim to slow disease progression, PIPE-791 targets a different biological pathway, potentially offering improved outcomes. Researchers are excited about PIPE-791 because it may address the underlying causes of lung tissue scarring more effectively, providing hope for better quality of life for patients with IPF.

What evidence suggests that PIPE-791 might be an effective treatment for Idiopathic Pulmonary Fibrosis?

Research shows that PIPE-791 is a medicine that blocks a specific part of the body involved in tissue thickening and scarring, known as fibrosis. Earlier studies demonstrated that PIPE-791 can reduce fibrosis and related signs in lab tests, suggesting it might help with conditions like idiopathic pulmonary fibrosis (IPF), a lung disease. Studies also found that PIPE-791 effectively reaches its target in both healthy people and those with progressive multiple sclerosis. These findings offer promising early evidence that PIPE-791 could help manage IPF by potentially slowing down or reducing lung scarring. Participants in this trial will receive either PIPE-791 at different dosages or a placebo to further evaluate its effectiveness and safety in treating IPF.12678

Who Is on the Research Team?

MO

Mudiaga O Sowho, MD, MPH

Principal Investigator

Contineum Therapeutics

Are You a Good Fit for This Trial?

This trial is for men and women over 40 years old who have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 7 years. Participants must show a certain lung function on tests and can join whether they're already taking approved IPF treatments or not. People with other specific health conditions are excluded.

Inclusion Criteria

I am 40 years old or older.
I was diagnosed with IPF within the last 7 years.
My lung function test shows at least 40% normal capacity.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PIPE-791 or placebo for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • PIPE-791

Trial Overview

The study is testing two different doses of PIPE-791 against a placebo to see how effective, safe, and tolerable it is for people with IPF. This Phase 2 trial randomly assigns participants to one of the groups without them or the researchers knowing which group they're in.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: PIPE-791 Dose BExperimental Treatment1 Intervention
Group II: PIPE-791 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Contineum Therapeutics

Lead Sponsor

Trials
7
Recruited
400+

Citations

Study to Evaluate the Efficacy, Safety, and Tolerability of ...

This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and PK of ...

Release Details

PIPE-791 achieved high LPA1 brain receptor occupancy (RO) in healthy volunteers and progressive multiple sclerosis (PrMS) patients.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40887574/

The LPAR1 antagonist, PIPE-791 produces antifibrotic ...

Conclusions: We show that PIPE-791 effectively reduces fibrosis and fibrotic markers in vitro and in vivo and that it has slow association and ...

Contineum Therapeutics Reports Third-Quarter 2025 ...

PIPE-791 is an LPA1 receptor antagonist in clinical development for idiopathic pulmonary fibrosis and chronic pain. PIPE-307 is a selective ...

Contineum PIPE-791 Phase 1b PET Trial Begins Patient ...

Specifically, it will measure how the concentration of PIPE-791 in the body relates to the occupancy of LPA1 receptors in the brain and lungs.

The LPAR1 antagonist, PIPE-791 produces antifibrotic effects ...

We show that PIPE-791 effectively reduces fibrosis and fibrotic markers in vitro and in vivo and that it has slow association and dissociation ...

PET Study of PIPE-791 in Healthy Volunteers and ...

This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF).

ex_860445.htm

PIPE-791 also demonstrated a safety and tolerability profile consistent with the Company's previous clinical studies. Based on these data, the ...